A wrongful death lawsuit filed against AbbVie alleges that the side effects of AndroGel and other testosterone replacement therapy make the drugs unfit for human use.

Mary Alfimow filed the complaint (PDF) in the U.S. District Court for the Eastern District of Pennsylvania on January 20, on behalf of herself and her deceased husband, Valerik Alfimow.

According to allegations raised in the wrongful death lawsuit, which was filed against AbbVie Inc. and Abbott Laboratories, the makers of Androgel, Alfimow died of cardiac arrest due to his use of the low testosterone gel.

Alfimow began using AndroGel in August 2010, after his doctor diagnosed him with hypogonadism. However, the lawsuit notes neither he nor his doctor were informed that the testosterone gel could increase the risk of heart attack, stroke, pulmonary embolism, deep vein thrombosis or death.

On January 20, 2014, Alfimow suffered cardiac arrest and died, which the lawsuit claims was the result of his use of AndroGel.

The case is one of about 3,500 testosterone drug lawsuits filed in U.S. District Courts nationwide, which have been consolidated for pretrial proceedings as part of a federal multidistrict litigation (MDL). The cases are all centralized before U.S. District Judge Matthew Kennelly in the Northern District of Illinois, for coordinated discovery and a series of early “bellwether” trials expected to begin next year.

Testosterone Health Risks

This recent lawsuit accuses AbbVie, and its former owner, Abbott Laboratories, of aggressively marketing AndroGel to men who did not need the medication, while failing to conduct proper studies to ensure the testosterone gel was safe.

“The marketing program sought to create the image and belief by consumers and physicians that low testosterone affected a large number of men in the United States and that the use of AndroGel is safe for human use, even though Defendants knew these statements to be false, and even though Defendants had no reasonable grounds to believe them to be true,” the lawsuit states. “There have been a number of studies suggesting that testosterone use in men increases the risk of heart attacks and strokes.”

Litigation over the testosterone blood clot risks emerged in November 2013, after a study published in the Journal of the American Medical Association (JAMA) found that certain men who began taking testosterone drugs following coronary angiography may be more likely to suffer cardiovascular events.

The FDA announced a warning label update for testosterone therapy in March 2015, indicating that new information would be added about the evidence of a link between testosterone drugs and heart problems. In addition, the agency encouraged doctors not to prescribe testosterone drugs for so-called “life-style” reasons, such as addressing decreased energy levels or sexual drive experienced by most men as they get older.

Following a series of bellwether trials in the MDL, if testosterone drug settlements are not reached by AbbVie and other manufacturers of low testosterone drugs, a second series of bellwether trials are expected to begin involving the use of other drugs.